Achaogen Announces Agreement with FDA on a Special Protocol Assessment for a Phase 3 Clinical Trial of Plazomicin to Treat Infections Caused by Carbapenem-Resistant Enterobacteriaceae (CRE)

South San Francisco, CA, September 23, 2013 – Achaogen, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 clinical trial of plazomicin in patients with serious multi-drug resistant (MDR) gram-negative bacterial infections. SPA agreement from the FDA indicates that the design and planned analyses of the clinical trial address objectives necessary to support a new drug application (NDA). This Phase 3 trial is designed as a superiority study to evaluate the efficacy and safety of plazomicin compared with colistin in patients with bloodstream infections and nosocomial pneumonia caused by CRE.

“Reaching agreement with the FDA on the plazomicin Phase 3 study design is a significant milestone for Achaogen as well as a meaningful step forward in antibiotic drug development for new regulatory pathways that address serious unmet medical needs,” said Kenneth Hillan, M.B. Ch.B, Chief Executive Officer and Chief Medical Officer for Achaogen. “FDA agreement on this protocol provides a clear path for a streamlined development plan for plazomicin. The trial is expected to start in fourth quarter, 2013.”

CRE are a global and growing public health concern. These bacteria are resistant to nearly all available antibiotics, including carbapenems, one of the last lines of defense against resistant infections. Mortality rates approach 50% in CRE patients with bloodstream infections, and the U.S. Centers for Disease Control and Prevention has categorized CRE as an “urgent” public health threat requiring immediate and aggressive action.

Plazomicin is a next-generation aminoglycoside antibiotic that Achaogen engineered to overcome key aminoglycoside resistance mechanisms. It has potent bactericidal activity against important gram-negative pathogens, including CRE. Plazomicin is also being developed for the treatment of infections caused by certain biothreat agents, including Yersinia pestis and Francisella tularensis (which cause plague and tularemia, respectively). The development of plazomicin is supported by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

About Achaogen
Achaogen is a biopharmaceutical company dedicated to discovering, developing, and commercializing treatments for serious infections caused by MDR gram-negative bacteria. In addition to its lead asset plazomicin, the company has active research and early development programs focused on novel mechanisms targeting gram-negative bacteria. Achaogen has established and advanced its specialized research and development capabilities using a blend of funding from private investors and partnerships with governmental entities, including BARDA, the National Institute of Allergy and Infectious Diseases, and the U.S. Department of Defense. For more information, please visit the company’s website at www.achaogen.com.

Media Contact:
Jennifer Cheung, Achaogen
1-650-452-6159
jcheung@achaogen.com

Investor Contact:
Dennis Hom, Achaogen
1-650-741-1237
dhom@achaogen.com

Pharmacokinetic/Pharmacodynamic (PK/PD) Assessment Predicts High Efficacy for Plazomicin Against Serious Infections Caused by Carbapenem-Resistant Klebsiella pneumoniae (CR Kp)

S. A. VanWart, A. Forrest, C. C. Bulik, P. G. Ambrose, C. F. Kostrub, A. Louie, G. L. Drusano, S. M. Bhavnani.
ICPD, Latham, NY; Achaogen, S. San Fransicso, CA; Inst for Therapeutic Innovation, Univ of FL, Orlando, FL.
ICAAC 2013, poster # A-1054c

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Pharmacokinetic-pharmacodynamics (PK-PD) predict a high probability of efficacy for plazomicin against serious infections caused by carbapenem-resistant Enterobacteriaceae (CRE)

S. A. Van Wart, A. Forrest, G. L. Drusano, S. M. Bhavnani, C. C. Bulik, C. F. Kostrub, P. G. Ambrose, A. Louie, Institute for Clinical Pharmacodynamics, Latham, NY, Institute for Therapeutic Innovation, University of Florida, Orlando, FL, Achaogen, Inc., South San Francisco, CA
ECCMID 2013, poster # P-914

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Plazomicin demonstrates potent efficacy against carbapenem-resistant enterobacteriaceae (CRE) in the neutropenic mouse thigh infection model

Arnold Louie, Corwin F. Kostrub, Steve Fikes, Weiguo Liu, Lee Ann Feeney, Lynn Connolly, George Drusano
Inst. For Therapeutic Innovation, Univ. of Florida, Orlando, FL; Achaogen, Inc., South San Francisco, CA
ECCMID 2013, poster # LB 2961

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The pharmacokinetics (PK) and safety of plazomicin in subjects with renal impairment

V. Riddle, D. Cebrik, C. Kostrub, L. Ma, Scott A. Van Wart, K. J. Hillan
BioPharmAdvisors LLC, Crofton, MD, USA; AxiStat, Inc., San Francisco, CA, USA; Achaogen, Inc., S. San Francisco, CA, USA; Institute for Clinical Pharmacodynamics, Latham, NY, USA
ECCMID 2013, poster # P-918

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A double-blind, randomized, placebo-controlled study to assess the safety, tolerability, plasma pharmacokinetics and lung penetration of intravenous plazomicin in healthy subjects

Robert Cass, Corwin F Kostrub, Mark Gotfried, Keith Rodvold, Kenneth J Tack, Jon Bruss
Achaogen Inc., South San Francisco, CA, Pulmonary Associates, Phoenix, AZ, University of Illinois, Chicago, IL, Medpace Inc., Cincinnati, OH.
ECCMID 2013, poster # P-1637

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Achaogen Awarded $60M Contract Option by BARDA for the Clinical Development of Plazomicin

- Contract to fund Phase 3 superiority study of plazomicin in patients with carbapenem-resistant Enterobacteriaceae (CRE) infections -

South San Francisco, CA, April 24, 2013 – Achaogen, Inc. today announced the award of a $60M contract option from the Biomedical Advanced Research and Development Authority (BARDA). The option supports the conduct of a global Phase 3 superiority study that will evaluate the efficacy and safety of plazomicin in treating patients with serious gram-negative bacterial infections due to CRE.  This pathogen-specific clinical study represents a new development approach to address unmet medical needs for multi-drug resistant bacterial infections. The study is expected to start in fourth quarter of 2013.

“We are excited and honored to continue the development of plazomicin in partnership with BARDA,” said Kenneth J. Hillan, M.B. Ch.B., Chief Executive Officer and Chief Medical Officer of Achaogen. “The growing prevalence of CRE infections poses a substantial public health threat, given the high mortality rates associated with CRE infections. Plazomicin’s strong potential to address this public health issue and to contribute to the global effort to guard against bacterial biothreats makes it a critically important agent in the antibacterial pipeline.”

Plazomicin is a next-generation aminoglycoside antibiotic that Achaogen engineered to overcome key aminoglycoside resistance mechanisms. It has potent bactericidal activity against important gram-negative pathogens, including strains resistant to carbapenem antibiotics – one of the last lines of defense against resistant infections. Plazomicin is also being developed for the treatment of infections caused by certain biothreat agents, including Yersinia pestis, which causes plague, and Francisella tularensis, which causes tularemia.

The contract option was issued under BARDA’s Broad Spectrum Antimicrobials (BSA) program, extending Achaogen’s original contract awarded in September of 2010 with initial committed funding of $27M. In 2012, BARDA exercised an additional $16M contract option. The new option announced today brings the total value of the contract to $103M.

About Achaogen
Achaogen is a biopharmaceutical company dedicated to discovering, developing, and commercializing treatments for serious infections caused by multi-drug resistant (MDR) gram-negative bacteria. In addition to plazomicin, the company's pipeline includes ACHN-975, a first-in-class LpxC enzyme inhibitor which is currently in Phase 1 clinical development. Achaogen has established and maintained its specialized research and development capabilities using a blend of funding from private investors and partnerships with governmental entities, including BARDA, the National Institute of Allergy and Infectious Diseases, and the U.S. Department of Defense. For more information, please visit the company’s website at www.achaogen.com.

Media Contact:
Jennifer Cheung, Achaogen
1-650-452-6159
jcheung@achaogen.com

Investor Contact:
Dennis Hom, Achaogen
1-650-741-1237
dhom@achaogen.com